-NEW- Manufacturing Engineer/ Senior Engineer (Medical Devices)

AMBITION GROUP SINGAPORE PTE. LTD.; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

AMBITION GROUP SINGAPORE PTE. LTD. is seeking an experienced manufacturing engineer to optimize manufacturability and guide technology transfer from R&D to production. The role emphasizes DFM/DFA input, process development, and risk mitigation across QA and regulatory requirements.

You will lead process validation efforts, equipment qualification, and training of manufacturing teams to improve yield, reliability, and compliance. Immediate start is preferred in Singapore.

Qualifications

• Bachelor's degree in a related discipline.
• At least 5 years of relevant manufacturing experience.
• Ability to start immediately or with short notice.

Responsibilities

• Provide DFM/DFA input during product design and development to optimize manufacturability, assembly, reliability, quality, and cost.
• Lead manufacturing process development, characterization, optimization, and validation, including IQ/OQ/PQ for new products and production lines.
• Support NPI, design transfer, and technology transfer from R&D to manufacturing, ensuring production readiness and scalable processes.
• Develop and qualify manufacturing equipment, fixtures, jigs, tooling, test systems, workflows, and detailed work instructions.
• Perform DFMEA/pFMEA, risk assessments, process validation, and test method development to mitigate product and manufacturing risks.
• Collaborate with R&D, Quality, Regulatory, Supply Chain, and Operations to resolve technical issues and deliver project milestones.
• Prepare and maintain controlled documentation supporting QMS and regulatory requirements, including ISO 13485, ISO 14971, FDA requirements, and applicable regulatory submissions.
• Provide technical guidance and training to manufacturing teams while driving process improvements in quality, yield, efficiency, reliability, and compliance.
• Adhoc tasks and projects as assigned

Skills

DFM/DFA input

Manufacturing process development

IQ/OQ/PQ for new products

design transfer

regulatory/compliance guidance

Education

Bachelor's degree in a related field

Job description

Job Responsibilities

• Provide DFM/DFA input during product design and development to optimize manufacturability, assembly, reliability, quality, and cost.
• Lead manufacturing process development, characterization, optimization, and validation, including IQ/OQ/PQ for new products and production lines.
• Support NPI, design transfer, and technology transfer from R&D to manufacturing, ensuring production readiness and scalable processes.
• Develop and qualify manufacturing equipment, fixtures, jigs, tooling, test systems, workflows, and detailed work instructions.
• Perform d FMEA/pFMEA, risk assessments, process validation, and test method development to mitigate product and manufacturing risks.
• Collaborate with R&D, Quality, Regulatory, Supply Chain, and Operations to resolve technical issues and deliver project milestones.
• Prepare and maintain controlled documentation supporting QMS and regulatory requirements, including ISO 13485, ISO 14971, FDA requirements, and applicable regulatory submissions.
• Provide technical guidance and training to manufacturing teams while driving process improvements in quality, yield, efficiency, reliability, and compliance.
• Adhoc tasks and projects as assigned

Job Requirements

• Minimum Degree in a related discipline
• Minimum 5 year of relevant experience
• Able to start immediately or within short notice